Feasibility and Reproducibility of Barostat Assessments of Colorectal Sensation During Colorectal Distention and Its Pharmacological Modulation Using Octreotide

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00584298
First received: December 21, 2007
Last updated: May 7, 2009
Last verified: May 2009
  Purpose

This study is designed to provide information on feasibility and reproducibility of barostat assessments of colorectal sensory functions and compliance and their pharmacological modulation


Condition Intervention Phase
Irritable Bowel Syndrome (IBS)
Drug: SMS995
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Women With Irritable Bowel Syndrome to Evaluate Feasibility and Reproducibility of Barostat Assessments of Colorectal Sensation During Colorectal Distention and Its Pharmacological Modulation Using Octreotide.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • - 5 sensory pressure thresholds [mmHg] from ascending method of limits (AML) barostat protocol. - 16 sensory intensity ratings from the random phasic distention (RPD) barostat protocol. [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - colorectal compliance [ Time Frame: throughout the study ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: January 2008
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: SMS995
Other Name: Octreotide, Sandostatin
Placebo Comparator: 2 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A positive diagnosis of IBS.
  • Subjects must either have been surgically sterilized, hysterectomized at least 6 months prior to screening, be postmenopausal or be using a double-barrier local
  • contraception.
  • Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent

Exclusion Criteria:

  • History of or evidence for structural diseases/conditions that affect the gastrointestinal system.
  • Other diseases or conditions that in the opinion of the Investigator significantly affect colorectal sensitivity.
  • Evidence of occult blood at stool analysis, or history of rectal bleeding.
  • Using or planning to use drugs or agents during the study period that alter GI physiology and visceral perception.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584298

Locations
United States, Massachusetts
Novartis Investigator Site
Boston, Massachusetts, United States, 02215
United States, Minnesota
Novartis Investigator Site
Rochester, Minnesota, United States, 55905
Canada
Novartis Investigator Site
Hamilton, Canada
Sweden
Novartis Investigator Site
Gothenburg, Sweden
United Kingdom
Novartis Investigator Site
London, United Kingdom
Novartis Investigator Site
Manchester, United Kingdom
Novartis Investigator Site
Nottingham, United Kingdom
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: NOVARTIS Novartis investigator site
  More Information

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00584298     History of Changes
Other Study ID Numbers: CSMS995A2101
Study First Received: December 21, 2007
Last Updated: May 7, 2009
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Sweden: Medical Products Agency

Keywords provided by Novartis:
Barostat
distention
IBS
irritable
bowel
syndrome
colorectal
sensation
modulation
reproducibility

Additional relevant MeSH terms:
Dilatation, Pathologic
Irritable Bowel Syndrome
Pathological Conditions, Anatomical
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Octreotide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 17, 2014